RANDOMIZED TRIAL OF 11-14 WEEK AMNIOCENTESIS AND TA CVS

本申请书随附一份题为《11-14年度随机试验》的提案 每周羊膜穿刺术和TA CVS“由莱尔德·杰克逊博士提交 由12个临床中心组成的集团。这些提案加在一起要求提供资金 一项多中心羊膜穿刺术的随机临床试验 妊娠77~14天经腹取绒毛(TA CVS)。 这项申请提出了乔治华盛顿大学/生物统计学 中心作为研究的数据协调中心(DCC)。目的 本研究旨在比较两种产前诊断技术的优劣。 安全性，主要通过胎儿丧失或死亡的综合终点来衡量 在怀孕196天之前早产，以及胎儿完全丧失， 羊水、分娩时胎龄、围产期发病率、新生儿 发病率和先天畸形，包括肢体缩小效应。 从这两个程序中获得诊断的成功与否将被比较。 一项辅助研究将评估以下项目的可行性和准确性 荧光原位杂交(FISH)作为一种快速诊断方法 某些细胞遗传学异常。 共有6400名怀孕77至104天的健康孕妇，她们 产前诊断的唯一适应症是高龄产妇至少 登记时满34岁或前次怀孕三体将被视为 在基线后随机接受TA CVS或羊膜穿刺术 超音波。5000名符合条件的妇女拒绝随机化或 不能在104天前安排手术的人也将被跟踪，一 其中数千人将接受标准的羊膜穿刺术。 发展协调委员会将通过以下方式协助小组实施研究：(1)设置 建立随机化程序；(2)培训研究人员；(3)设置 建立计算机数据处理和编辑系统；(4)监测 招聘、遵守方案和数据质量；(5)准备中期 对安全监察委员会的结果进行分析；(6)进行 最终分析和准备公布结果；及(7) 记录最终的数据库。

This application accompanies a proposal entitled "Randomized Trial of 11-14 Week Amniocentesis and TA CVS" submitted by Dr. Laird Jackson leading a group of twelve clinical centers. Together the proposals request funding for a multi-center randomized clinical trial of amniocentesis and transabdominal chorionic villus sampling (TA CVS) at 77-14 days gestation. This application proposes The George Washington University/Biostatistics Center as the Data Coordinating Center (DCC) for the study. The purpose of the study is to compare the two prenatal diagnosis techniques with regard to safety, measured primarily by a combined endpoint of fetal loss or preterm delivery before 196 days gestation and also by total fetal loss, amniotic fluid, gestational age at delivery, perinatal morbidity, neonatal morbidity and congenital abnormalities, including limb reduction effects. Success in obtaining a diagnosis from the two procedures will be compared. An ancillary study will evaluate the feasibility and accuracy of fluorescence in situ hybridization (FISH) as a rapid diagnostic method for certain cytogenetic abnormalities. A total of 6400 healthy pregnant women at 77 to 104 days gestation, whose only indication for prenatal diagnosis is advanced maternal age of at least 34 years at enrollment or trisomy in a previous pregnancy will be randomized to receive either TA CVS or amniocentesis following a baseline ultrasound. Five thousand eligible women who refuse randomization or for whom a procedure cannot be scheduled by 104 days will also be followed, one thousand of whom will have a standard amniocentesis procedure. The DCC will assist the group in implementing the study by: (1) setting up a randomization procedure;' (2) training study personnel; (3) setting up a computerized data processing an editing system; (4) monitoring recruitment, protocol adherence and data quality; (5) preparing interim analyses of the results for a Safety monitoring Committee; (6) conducting final analyses and preparing the publication of results; and (7) documenting the final data base.